Clinical Trials Office

Teens with Fibromyalgia Needed for Research Study

What is the purpose of this study?

This research study wants to see which of two group-based training programs, Fibromyalgia Integrative Training Program for Teens (FIT Teens) and Cognitive-Behavioral Therapy (CBT), is more effective for helping teens with juvenile fibromyalgia (JFM) manage their symptoms.

FIT Teens is a specially designed program to help improve physical fitness and coping, and reduce pain symptoms.

CBT focuses on improving psychological coping skills without a physical exercise component to help improve coping and function.

Each training program lasts for 8 consecutive weeks.

Who can participate?

Those eligible for participation are teenagers, 12 to 18 years old, who have a diagnosis of JFM, at least moderate pain and difficulty with their usual activities (like sports or school) because of pain.

Conditions

  • Fibromyalgia

What is involved?

Your child will be in this research study for about 22 weeks (five-and-a-half-months) and attend three assessment sessions and 16 group treatment sessions (two times per week for eight weeks).

Teens who are eligible for the study will be randomly assigned (like flipping a coin) into one of two study groups, CBT or FIT Teens.

All teens will attend three assessment sessions (one at the beginning of the study, one after the treatment is over and one at the three-month follow-up) which will consist of answering brief questionnaires, wearing an activity monitor, and testing of their balance, strength and fitness. Each assessment session should last about two hours.

Teens randomized into the CBT group will attend two, 30 to 45 minute small group treatment sessions (of about six teens per group) per week. During those treatment sessions, teens will work with a psychology trainer to teach them coping skills to manage pain. Parents will attend some of the sessions with their child.

Teens randomized into the FIT Teens group will attend two, 1.5 hour small group treatment sessions (of about six teens per group) per week. During those treatment sessions, teens will work with an exercise trainer and psychology trainer to teach them neuromuscular exercises to improve their strength, fitness and body mechanics and coping skills to manage pain. Parents will attend some of the sessions with their child.

A detailed list of procedures will be provided to anyone interested in knowing more about this study.

What are the benefits?

Your child may or may not receive a direct medical benefit from participating in this study. However, the information learned from this study will allow us to develop better treatment programs which might benefit other teenagers with JFM in the future.

Will I get all the facts about the study?

If you are interested in your child participating, you will be given a consent form that explains all of the details of the study. The form covers all of the procedures, risks, benefits, pay, whom to contact with questions or concerns and more. A member of the study staff will review the consent form with you and will be sure that all of your questions are answered.

Do participants receive pay, compensation or reimbursement?

Participants may receive up to $360 for their time and travel. After completing the study, participants may also receive either a BOSU Balance Training Ball or relaxation gift basket

Who should I contact for more information?

Study Coordinator
513-636-0368
Cincinnati Children’s Hospital Medical Center
3333 Burnet Avenue
Cincinnati, OH 45229-3039

Where can I find additional information?

Principal Investigator

Susmita Kashikar-Zuck, PhD
Behavioral Medicine and Clinical Psychology
Cincinnati Children’s Hospital Medical Center